Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-28 @ 11:55 PM
Study NCT ID:
NCT02016092
Status:
UNKNOWN
Last Update Posted:
2016-03-14
First Post:
2013-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Discovery in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood \\& Urine Specimen Collection: Up to 20mL of venous blood samples will be collected for plasma multi-omic analysis, as well as optional genetic, analyses.\n\nUrine samples (\\~50ml) will be collected via sterile urine cup and transferred into appropriate urine tube for multi-omic analysis.\n\nAll Samples may be saved for future studies, if consented.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-10', 'studyFirstSubmitDate': '2013-12-14', 'studyFirstSubmitQcDate': '2013-12-14', 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Biological markers of Parkinson's disease", 'timeFrame': '18 months', 'description': "To identify biologic markers of Parkinson's Disease (PD) for use in diagnostic testing."}], 'secondaryOutcomes': [{'measure': 'Correlation between biologic markers and clinical features of PD', 'timeFrame': '36 months', 'description': 'To identify and investigate possible correlations between biologic markers and clinical features of PD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'biomarkers', 'blood', 'urine,', 'proteomics', 'lipidomics', 'metabolomics'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "There are approximately one million Americans who live with Parkinson's disease with 50,000 new cases per year and this rate is expected to rise with an aging population. The underlying pathophysiology and disease understanding of PD still remains elusive due to a combination of disease complexity and lack of predictive capability of existing models.\n\nThe Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in producing drug targets and biomarkers that truly represent a disease phenotype. It has been able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS) diseases. The platform is able to decipher normal versus disease signatures by integration of data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that is subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then put back into wet-lab validation before proceeding to proof-of-principle pre-clinical testing.\n\nBy utilizing clinical data and specimens obtained by the medical specialists at The Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's patients", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor PD cases:\n\nInclusion Criteria:\n\n* Men and women with the clinical diagnosis of idiopathic PD\n* Willing and able to give informed consent\n* Willing and able to comply with scheduled visits, required study procedures and laboratory tests\n\nExclusion Criteria:\n\nPD Subjects with any of the following may not be enrolled:\n\n1. Presence of atypical or secondary parkinsonism\n2. Inability to provide a blood and/or urine sample\n3. History of renal failure and/or on dialysis\n4. Currently taking a medication in the following categories: dopamine blockers, neuroleptics, and/or dopamine blocking agents.\n5. Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation\n\nHealthy Controls:\n\nAll of the following criteria must be met for a Healthy Control to be enrolled in the study:\n\n1. Healthy controls with no diagnosis of PD and any of the exclusion criteria\n2. Willing and able to give informed consent\n3. Willing and able to comply with scheduled visits, required study procedures and laboratory tests\n\nHealthy Controls with any of the following may not be enrolled:\n\n1. No clinically significant or unstable medical or psychiatric condition that would interfere with the conduct of the study\n2. Diagnosis of PD or presence of signs of a neurodegenerative disorder, e.g. essential tremor\n3. First degree relative with PD/parkinsonism\n4. Inability to provide a blood and/or urine sample\n5. History of renal failure and/or on dialysis\n6. Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation'}, 'identificationModule': {'nctId': 'NCT02016092', 'acronym': 'DISCOVERY-PD', 'briefTitle': "Biomarker Discovery in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': "The Parkinson's Institute"}, 'officialTitle': "Proteomics, Metabolomics, Lipidomics and Genetic Analysis for Biomarker DISCOVERY in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'ECH-13-24'}, 'secondaryIdInfos': [{'id': '5258', 'type': 'OTHER_GRANT', 'domain': 'Berg Pharma, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients with Parkinson's disease"}, {'label': 'Healthy Controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94085', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': "The Parkinson's Institute and Clinical Center", 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available, summary datasets may be published in peer-review journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Parkinson's Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Birgitt Schuele', 'investigatorAffiliation': "The Parkinson's Institute"}}}}